Penumbra touts non-inferiority in Compass aspiration thrombectomy trial

Penumbra (NYSE:PEN) late last month released results from the Compass trial of its aspiration thrombectomy system designed to treat acute ischemic stroke, touting that the system was shown to be non-inferior to stent retrievers.

Results from the trial were presented at the International Stroke Conference, the Alameda, Calif.-based company said.

Investigators in the trial aimed to compare the use of Penumbra’s aspiration thrombectomy system, which uses a suction to remove clots, against traditional stent retrievers in treating patients with acute ischemic stroke.

Results from the study indicated 52% of patients treated with the Penumbra aspiration system achieved the primary endpoint of a modified Rankin Score of 0 to 2 within 90 days compared to 49% of patients treated with stent retrievers.

“The primary outcome was demonstrating non-inferiority in clinical outcome between the patients, and it’s the first trial designed specifically to access clinical outcome in non-inferiority between these two cohorts. The results demonstrate clearly non-inferior outcomes, with 52% of the aspiration first cohort achieving independence and 49% of the second cohort demonstrating independence, and the persistence of non-inferiority was consistent across multiple sensitivity analyses,” lead investigator Dr. J. Mocco of the Icahn School of Medicine at Mount Sinai told MassDevice.com in an interview.

Final revascularization rates were similar between both cohorts, with 92% of patients treated with Penumbra’s aspiration system achieving mTICI 2b-3 revascularization versus 89% of the stent retriever cohort. A total 38% of patients in the aspiration arm achieved TICI 3, versus 29% of patients in the stent retriever arm.

Secondary safety points, including embolization in new territory and symptomatic intracranial hemorrhage were not statistically different between cohorts.

The results are bigger than just non-inferiority to Dr. Mocco, who said he’s hopeful that these results, along with other studies on thrombectomy systems, will increase the likelihood and availability of such procedures to patients who desperately need them.

“There’s a tremendous amount to still be learned, both in the approach and technical components of thrombectomy, as well as in patient selection, and that’s most importantly in patient access. What I hope is that, with Compass, the conversation can move beyond an over-emphasis of a specific technology versus another and allow the community to focus on these incredibly important issues of patient selection and patient access. Right now, approximately 10% of patients that could benefit from thrombectomy have a shot at getting thrombectomy. So, there is clearly a dire need for us to prove our ability to get patients these important therapies, and it’s better if Compass’ results help to step along that path – that’d certainly be a tremendous win,” Dr. Mocco said.

The data also reinforced previous results from Penumbra trials of the aspiration system, the company said, and serves as the first in three randomized trials using the Ace 68 reperfusion catheter with the Penumbra system.

“The Compass Trial, together with the Promise, Aster, and 3D Trial results, provides overwhelming evidence that the Adapt technique with the Penumbra System is a proven frontline approach. Notwithstanding this great data, Penumbra will continue to innovate and improve its Penumbra System; however, all of us in the stroke field now have an obligation to ensure all ischemic stroke patients have access to hospitals that offer mechanical thrombectomy for the best possible outcomes,” chair, CEO & prez Adam Elsesser said in a press release.

Earlier in January, Penumbra released results from the Promise real-world safety and efficacy study of its Penumbra System with ACE 68 and 64 reperfusion catheters as a treatment for patients with acute ischemic stroke, touting high rates of revascularization and low rates of all-cause mortality.

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